Sr SSU & Regulatory Specialist
Syneos Health
Buenos Aires, Argentina
hace 6 horas

JOB SUMMARY

Performs assigned activities within the country that lead to start-up ofinvestigative sites in all phases of clinical trials.

Responsible for providingdelivery and expertise, with minimal oversight from the SSU Country Manager inone or more of the following functional areas : investigator site contracts,ethics and regulatory submissions, and review and finalization of essentialdocuments required for site initiation.

Accountable local activities are undertakenin accordance with agreed timelines, allocated budgets, and required qualitystandards.

Ensures an efficient start-up process on assigned studies.May act as main contact with RegulatoryAuthorities (RA) and Central / Regional Ethics Committees (ECs).

Under thedirection of the Project Lead (PL) or SSUL as appropriate, may directlyinteract with Customers when receive requirements from RA or other localregulatory party.

Accountable to the PL / SSUL at the project level and linemanager for deliverables. May act as the Country Start-Up Advisor (CSA) or as aline manager / mentor for less experienced staff.

At a project level, may actas SSUL for local or regional studies.

JOB RESPONSIBILITIES

  • General Responsible for quality deliverables at the country level; follows projectrequirements and applicable country rules, with minimal oversight from the SSUCountry Manager.
  • Forecastssubmission / approval timelines, ensures compliance and tracks milestone progressin agreed upon SSU tracking system in real time;
  • if forecasted timelines arenot reached analyses data to provide clear rationale for delays, providescontingency plans to mitigate impact, and escalates the issue as soon as identified.

    Monitors financial aspects of the project andthe number of hours / tasks available per contract; escalates discrepancies in atimely fashion.

    Reviews and complieswith Standard Operating Procedures (SOPs) and Work Instructions (WI) in atimely manner, keeps training records updated accordingly and ensures timesheetcompliance.

    Ensures all relevantdocuments are submitted to the Trial Master File (TMF) as per companySOP / Sponsor requirements.Ensurescontinuous improvement of quality in all Site Start-Up (SSU) components at thecountry level where assigned (submissions, essential document collection,communication to Competent Authorities and ECs, etc.

    May be involved in vendor management.

    Responsible for one or more of thefollowing functions at the country level :

  • Local Submissions Specialist - Follows the project direction andexpertise provided by the designated country start-up advisor (CSA) andPM / SSUL.
  • May serve as the primary pointof contact for the PM / SSUL (or designee) during start-up on allocatedprojects.Compiles and / or reviewsessential document packages for site activation and may also be involved inessential document collection from site.

    Prepares and submits Central EC Applications, Local EC Applications, RA Applications,and other local regulatory authorities or hospital approval submissions asrequired.

  • Overseesongoing submissions, amendments, and periodic notifications required by centraland local EC and RA, and other local regulatory authorities as needed withinthe country;
  • includes safety notifications as required by local rules, withminimal oversight from the SSU Country Manager.

  • CountryStart-Up Advisor - Acts as Subject Matter Expert for in-country performancewithin the Site Start-Up.Acts as country-levelintelligence on start-up (SU) and clinical trial regulatory (CTR).
  • Ensures that local country regulatoryintelligence, as it pertains to the activities of the local SU and CTR team, ismaintained on the central repository, e.

    g., Competent Authority submissions, ECsubmissions, notifications to data protection authorities,notifications / applications to any other local / federal / national body, andimport / export license applications where these are obtained with RAapplications.

    In absence of legaladvisor or subject matter advisor for data protection at the country, providesclear data protection guidance at a country level on data protection statementsthat need to be included on those documents which the Sponsor has contracted tothe Company start-up group to adapt to local requirements.

    This will typically include the PrincipalInvestigator / Informed Consent and the Confidential DisclosureAgreement / contract template.

    Providesinput in local SOPs and WI.Support forthe creation of internal training materials on for local legislationrequirements.

    Responsible to identifysolutions with EC or CA issue resolution at the country level.

  • LocalSite ID and Feasibility Support Provides support site selection lead andPM / SSUL to ensure that the appropriate sites are selected for individualstudies based on the requirements of the clinical trial.
  • LocalInvestigator Contract and Budget Negotiator - Produces site-specific contractsfrom country clinical trial agreement (CTA) template.
  • Reviews and owns site-specific contracts from country template.Submitsproposed CTA and investigator budget for site review.

    Negotiates budget and contract with site andvia Site Contracts Service Centre and SSUL with Sponsor until resolution ofissues.

    Performs quality control and arrangesexecution of CTAs as well as archival of documents into repositories andcapture of metadata.

  • Linemanagement / mentoring responsibilities As part of developmental plans, itmay be requested to provide support to management in activities such as interviewingand selection, professional development, performance management, and employeecounseling and separations.
  • Advisesjunior team members on administrative policies and procedures, technicalproblems, priorities and methods.

  • Ensureall relevant documents are submitted to the Trial Master File (TMF) as per CompanySOP / Sponsor requirements.
  • Qualifications

    QUALIFICATION & REQUIREMENTS(please indicate if preferred’)

  • Bachelor’s Degree
  • Excellentunderstanding of clinical trial process across Phases II-IV and ICH GCP
  • Goodunderstanding clinical protocols and associated study specifications
  • Excellent understanding of clinical trialstart-up processes
  • Projectmanagement experience in a fast-paced environment
  • Goodvendor management skills
  • Strongorganizational skills with proven ability to handle multiple projects
  • Excellentcommunication, presentation and interpersonal skills
  • Quality-drivenin all managed activities
  • Strong negotiatingskills
  • Strongproblem-solving skills
  • Abilityto mentor, lead and motivate more junior staff
  • Demonstratean ability to provide quality feedback and guidance to peers
  • Contributeto a training and Quality assurance plan within SSU and update SOPs / WI
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